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SCOUT Localization for Breast Cancer

N/A
Recruiting
Led By C Desbiens, MD
Research Sponsored by Merit Medical Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lesion depth is < 6 cm from skin surface
Woman >18 years and < 80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights

Study Summary

This trial is designed to show that the SCOUT system can help improve efficiency in Canadian breast cancer centers, and to further assess the system's safety and performance.

Who is the study for?
This trial is for women aged 18-80 with a specific breast cancer suspicion level (BI-RADS 4C or 5), non-palpable lesions less than 6 cm deep. Participants must consent to the study. It excludes those with multicentric breast cancer, nickel-titanium allergies, and pregnant or lactating women.Check my eligibility
What is being tested?
The STREAMLoc trial is testing the SCOUT® system's effectiveness and safety in localizing breast lesions during biopsy within Canadian and US healthcare settings. The goal is to evaluate how well it works under fixed resources while minimizing harm exposure.See study design
What are the potential side effects?
While specific side effects are not detailed here, typical risks may include discomfort at the biopsy site, potential allergic reactions to materials used in SCOUT®, and standard risks associated with any invasive diagnostic procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is less than 6 cm deep from the skin.
Select...
I am a woman aged between 18 and 80.
Select...
My cancer cannot be felt by touch.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of invasive visits
Secondary outcome measures
Adverse event rate
Performance

Trial Design

1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 Intervention
Receives SCOUT at biopsy

Find a Location

Who is running the clinical trial?

Merit Medical Systems, Inc.Lead Sponsor
30 Previous Clinical Trials
3,155 Total Patients Enrolled
C Desbiens, MDPrincipal InvestigatorSt. Sacrement

Media Library

Receives SCOUT at biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04815291 — N/A
Breast Cancer Research Study Groups: Device
Breast Cancer Clinical Trial 2023: Receives SCOUT at biopsy Highlights & Side Effects. Trial Name: NCT04815291 — N/A
Receives SCOUT at biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04815291 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being investigated in this research?

"Affirmative. The information on clinicaltrials.gov indicates that the trial is currently recruiting participants, with initial posting dated April 1st 2022 and most recent update from November 16th 2022. This experiment requires 500 people to be enrolled at a single location."

Answered by AI

Are there any open enrollments for this clinical trial?

"Clinicaltrials.gov reports that this clinical trial is still recruiting participants, having been published on April 1st 2022 and last updated November 16th 2022."

Answered by AI

May I be permitted to take part in this experiment?

"The breast cancer trial is recruiting 500 participants aged between 18 and 80. Those that meet the criteria may be selected for this groundbreaking research."

Answered by AI

Do the requirements for this trial extend to adult participants?

"This trial is accepting participants aged between 18 and 80. However, for those younger than 18 or older than 65 there are 52 and 1335 clinical trials respectively that may be suitable."

Answered by AI
~132 spots leftby Feb 2025